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Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter

FDA UDIEUDAMED

Class III (US FDA UDI)

Ref C2KIVL2512Ref C2KIVL3512

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave C2+ Coronary IVL Catheter EUDAMED
Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter FDA UDI
Generic Name
Intravascular lithotripsy system balloon catheter, coronary FDA UDI
Device Name
Shockwave C2+ Coronary IVL Catheter, Procedure Pack EUDAMED
The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. FDA UDI
Model / Reference
C2KIVL2512 EUDAMED
C2KIVL3512 EUDAMED
C2PIVL3012 FDA UDI
Description
The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery. FDA UDI

Identifiers

Catalog Number
C2PIVL3012 FDA UDI
Primary DI / UDI-DI
00195451000423 EUDAMED
00195451000447 EUDAMED
00195451000010 FDA UDI
Basic UDI-DI
00195451C2KIVLXX EUDAMED
PMA Number
P200039 FDA UDI
FDA Product Code
QMG FDA UDI
EMDN Code
C01040199 CARDIAC ANGIOGRAPHY DEVICES - OTHER EUDAMED
GMDN Term
Intravascular lithotripsy system balloon catheter, coronary FDA UDI

Classification

Device Class
Class III EUDAMEDFDA UDI
Medical Purpose
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Balloon Length — 12 Centimeter FDA UDI
Balloon Diameter — 3.0 Millimeter FDA UDI
Balloon Proximal Outer Diameter (OD) — 0.045 Inch FDA UDI
Length — 138 Centimeter FDA UDI
Guidewire Compatibility — 5 French FDA UDI

Category: Intravascular lithotripsy system balloon catheter, coronary

Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter by Shockwave Medical, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Intravascular lithotripsy system balloon catheter, coronary.

Cleared under the same submission

P200039 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shockwave Medical, Inc.

Sources (3)

  • FDA UDI a5a632cb-4520-4945-ac5a-96241629f81c 38 fields · synced Aug 2, 2026
  • EUDAMED 522d2d62-102c-4ca7-99b8-fcad8407b78c 61 fields · synced Jul 18, 2026
  • EUDAMED fc2229d5-5fe4-4812-a57c-09d52efd7db9 61 fields · synced Aug 2, 2026